Association
of American Physicians and Surgeons, Inc.
A Voice for Private Physicians Since 1943Omnia pro aegroto

STATEMENT
of the
ASSOCIATION OF AMERICAN PHYSICIANS & SURGEONS

to the
Subcommittee on Criminal Justice, Drug Policy, and Human
Resources
of the Committee on Government Reform
U.S. House of Representatives

RE: HEPATITIS B VACCINE

Submitted by Jane Orient, M.D.
June 14, 1999

Mr. Chairman and Members of the Subcommittee:

My name is Jane Orient, M.D. I am a practicing internist from Tucson, Arizona, and
serve as the Executive Director of the Association of American Physicians & Surgeons (“AAPS”).

AAPS is a nationwide organization of physicians devoted to defending the sanctity of the
patient-physician relationship. AAPS revenue is derived almost exclusively from membership
dues. We receive no government funding, foundation grants, or revenue from vaccine
manufacturers. No members of our governing body (the Board of Directors), have a conflict of
interest because of a position with an agency making vaccine policy or any entity deriving profits
from mandatory vaccines.

AAPS thanks this Committee and Chairman Mica for leaving the record open for a longer
period to permit an opportunity to review the hearing transcript, written testimony, and raw data
from the Vaccine Adverse Event Reporting System (VAERS).

It is apparent that critical medical decisions for an entire generation of American children
are being made by small committees whose members have incestuous ties with agencies that stand
to gain power, or manufacturers that stand to gain enormous profits, from the policy that is
made. Even if such members recuse themselves from specific votes, they are permitted to
participate in discussions and thus influence the decision. Moreover, there is the potential for deal-
making. Or there may be a simple disinclination to cause problems for one member's agenda in
the expectation that that member will reciprocate.

Once a vaccine is mandated for children, the manufacturer and the physician
administering the vaccine are substantially relieved of liability for adverse effects. The relationship
of patient and physician is dramatically altered: in administering the vaccine, the physician is
serving as the agent of the state. To the extent that the physician simply complies without making
an independent evaluation of the appropriateness of the vaccine for each patient, he is abdicating
his responsibility under the Oath of Hippocrates to “prescribe regimen for the good of my
patients according to my ability and my judgment and never do harm to anyone.”

Should a physician advise against a mandated vaccine, he faces increased legal liability
should the patient acquire the disease. Moreover, he may risk his very livelihood if he is
dependent upon income from “health plans” that use vaccine compliance as a measure of
“quality.”

It is perhaps not surprising, although still reprehensible, that physicians sometimes behave
in a very callous manner toward parents who question the need for certain vaccines.

Federal policy of mandating vaccines marks a profound change in the concept of public
health. Traditionally, public health authorities restricted the liberties of individuals only in case
of a clear and present danger to public health. For example, individuals infected with a
transmissible disease were quarantined. Today, a child may be prevented from attending school
or associating with others simply because of being unimmunized. If there is not an outbreak of
disease and if the child is uninfected, his or her unimmunized state is not a threat to anyone. An
abridgement of civil rights in such cases cannot be justified.

With hepatitis B vaccine, the case for mandatory immunization with few exemptions is
far less persuasive than with smallpox or polio vaccines, which protected against highly lethal or
disabling, relatively common, and easily transmissible diseases. An intelligent and conscientious
physician might well recommend AGAINST hepatitis B vaccine, especially in newborns, unless
a baby is at unusual risk because of an infected mother or household contact or membership in
a population in which disease is common.

AAPS awaits the release of full information concerning the licensure of hepatitis B vaccine
and the mandate for newborn immunizations, as requested under the Freedom of Information
Act by the National Vaccine Information Center. It is imperative that independent scientists have
the opportunity to review the raw data. In the meantime, all coercive means for increasing the
immunization rate should be immediately discontinued. Fully informed consent should be sought
before vaccine is administered. This requires full and honest disclosure of the risks and
uncertainties of the vaccine, in comparison with the risks of the disease.

Information given to parents about this vaccine often does not meet the requirement for
full disclosure. For example, it may state that “getting the disease is far more likely to cause
serious illness than getting the vaccine.” This may be literally true, but it is seriously misleading
if the risk of getting the disease is nearly zero (as is true for most American newborns). It may also
be legalistically true that “no serious reactions have been known to occur due to the hepatitis B
recombinant vaccine.” However, relevant studies have not been done to investigate whether the
temporal association of vaccine with serious side effects is purely coincidental or not.

An independent review of the VAERS data; publications by governmental, pro-vaccine,
and anti-vaccine groups; and a sample of the medical literature leads to the following conclusions:

For most children, the risk of a serious vaccine reaction may be 100 times
greater than the risk of hepatitis B.

Overall, the incidence of hepatitis B in the U.S. is currently about 4 per 100,000. The risk
for most young children is far less; hepatitis B is heavily concentrated in groups at high risk due
to occupation, sexual promiscuity, or drug abuse.

VAERS contains 25,000 reports related to hepatitis B vaccine, about one-third of which
were serious enough to lead to an emergency room visit, hospitalization, or death. It is often
assumed that only 10% of reactions are reported. (This committee has heard testimony about
persons being actively discouraged from reporting, even if they are aware of the reporting
system.) Thus, if there have been some 80,000 serious adverse reactions associated with 20 million
doses of vaccine, the risk is about 4 in 1000.

(This calculation depends on many assumptions. Moreover, many of the patients
experiencing temporally associated adverse reactions had simultaneously received more than one
vaccine. Nevertheless, a better estimate has not been put forth.)

It should be noted that a less than 1 in 1,000,000 purely hypothetical risk may be used to
justify costly federal regulations on highly useful products that are used voluntarily.

In nearly 20% of VAERS reports, the first of eight listed side effects
suggests central nervous system involvement.

Examining the first listed effects shows about 4,600 involving such symptoms as
prolonged screaming, agitation, apnea, ataxia, visual disturbances, convulsions, tremors, twitches,
an abnormal cry, hypotonia, hypertonia, abnormal sensations, stupor, somnolence, neck rigidity,
paralysis, confusion, and oculogyric crisis. The last is a striking feature of post-encephalitic
Parkinson's disease, or it may occur as a dystonic reaction to certain drugs such as
phenothiazines.

The CDC admits that the results of ongoing studies on a potential association of hepatitis
B vaccine and demyelinating diseases such as multiple sclerosis are not yet available.

There may be large genetic differences in susceptibility to vaccine adverse
effects.

The committee has been told that serious reported adverse effects seem restricted to
Caucasians. Yet the oft-cited long-term safety study was conducted in Alaskan natives, and many
studies involved Asians. In adults, 77% of the reactions involve women, who are generally more
susceptible to autoimmune diseases. This deserves serious study, not off-hand dismissal (“nurses
always over-report”). Universal immunization could lead to disproportionate injury to susceptible
populations, who might also be the least affected by the disease one is trying to prevent.

Striking increases in chronic illnesses have occurred in temporal
association with an increase in vaccination rates.

Asthma and insulin-dependent diabetes mellitus, causes of lifelong morbidity and frequent
premature death, have nearly doubled in incidence since the introduction of many new,
mandatory vaccines. There is no explanation for this increase. The temporal association, although
not probative, is suggestive and demands intense investigation. Instead of following up on earlier,
foreign studies suggesting a greater-than-chance association, the CDC, through vaccine mandates,
is obliterating the control group (unvaccinated children).

Dr. Classen testified concerning his opinion that hepatitis B vaccine could precipitate
diabetes mellitus. Of note, VAERS contains more than 4,000 reports of abdominal symptoms that
could have been due to pancreatitis, which was probably not specifically sought and thus missed
if present.

Even more alarming is the huge increase in reports of autism and attention
deficit/hyperactivity disorder, with devastating, life-long impacts. Much of this could be due to
overdiagnosis (now rewarded by numerous government subsidies). The change in behavior that
many parents observe related to vaccines could be coincidental, or it might reflect a desperate
need to explain a disastrous occurrence. Nonetheless, the implications are so grave that immediate
investigation is needed. Measles, mumps, rubella, hepatitis B, and the whole panoply of childhood
diseases are a far less serious threat than having a large fraction (say 10%) of a generation afflicted
with learning disability and/or uncontrollable aggressive behavior because of an impassioned
crusade for universal vaccination.

There are plausible mechanisms such as molecular mimicry whereby vaccines could have
such effects. Basic research, as well as epidemiologic studies (starting with a long-term follow-up
of reactions reported to VAERS), is urgent.

Hepatitis B vaccine as a cause of sudden infant death has not been ruled
out.

The mere observation that the incidence of SIDS has decreased while hepatitis B
immunization rates have increased proves nothing whatsoever. In other contexts, the Back to
Sleep campaign is credited with a dramatic fall in SIDS; the fall might have been much greater
without hepatitis B immunizations. The presence of findings such as brain edema in healthy
infants who die very soon after receiving hepatitis B vaccine is profoundly disturbing, especially
in view of the frequency of neurologic symptoms in the VAERS.

Does SIDS occur on the day after hepatitis B vaccine with a greater-than-expected
frequency? Does it occur at a younger-than-expected age? Are the autopsy findings different in
babies who just received the vaccine? The fact that vaccine just happens to be given during the
time period that babies are most likely to die of SIDS complicates the analysis. Also, there are a
number of other confounding variables (sleep position, socioeconomic status, and possibly
smoking behavior).

The data in VAERS are probably too incomplete to answer the questions. A very detailed
statistical analysis and an aggressive attempt to obtain more complete information are urgently
needed. Glib reassurance, based on the secular trends shown to this Committee, is dangerous.

CONCLUSIONS

Public policy regarding vaccines is fundamentally flawed. It is permeated by conflicts of
interest. It is based on poor scientific methodology (including studies that are too small, too short,
and too limited in populations represented), which is, moreover, insulated from independent
criticism. The evidence is far too poor to warrant overriding the independent judgments of
patients, parents, and attending physicians, even if this were ethically or legally acceptable.

AAPS opposes federal mandates for vaccines, on principle, on the grounds that they are:

An unconstitutional expansion of the power of the federal government.

An unconstitutional delegation of power to a public-private partnership.

An unconstitutional and destructive intrusion into the patient-physician and parent-child
relationships.

A violation of the Nuremberg Code in that they force individuals to have medical
treatment against their will, or to participate in the functional equivalent of a vast
experiment without fully informed consent.

A violation of rights to free speech and to the practice of one's religion (which may require
one to keep oaths).

AAPS would specifically oppose the campaign for universal immunization against
hepatitis B, even if the above did not apply, because the safety of the vaccine is in
question.